跳至主要内容
临床试验/NCT07788898
NCT07788898尚未招募不适用

AI-enabled Communication to Advance Research Engagement

Albert Einstein College of Medicine1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Confidence in medical research and researchers - Aim 3

研究概览

简要总结

The objective of AI-CARE is to train researchers and community members to use artificial intelligence (AI) to create plain-language summaries of research studies and to determine whether a co-creation process for developing these summaries improves understanding and relevance of the research, confidence in AI and in institutions, and AI literacy. The hypothesis is that AI-generated research summaries, co-developed with researchers and community partners, will significantly improve confidence in research and institutions, understanding and accessibility of the research, and appropriateness of the summary compared with standard researcher-generated materials, and that the educational and co-creation process will build community members' AI literacy and confidence in using AI, as well as researchers' readiness to use and comfort with using AI for communicating research.

详细描述

This research project consists of four specific aims. Specific Aims 2 and 3 meet the NIH definition of a clinical trial. Accordingly, this ClinicalTrials.gov registration describes only the clinical trial conducted under Specifics Aims 2 and 3. The remaining aims involve non-interventional research activities and are not included in this registration. Aims 2 and 3 are an intentional sequential design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Aim 2: N/A Aim 3: Participants are blinded to how the research summaries were developed. The summaries are presented in identical formats without identifying the development method. Study personnel performing the primary analyses remain blinded to treatment assignment until completion of the primary analyses.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English-speaking individuals at least 18 years of age

排除标准

  • Individuals unable to provide informed consent
  • Participants who have had formal training in AI prompt engineering
  • The eligibility criteria are common to both Aims 2 and 3.

研究组 & 干预措施

Standard AI prompt - Aim 3

Experimental

Participants receive plain-language research summaries generated using a standardized AI prompt without researcher prompt engineering or community co-design.

干预措施: Experimental: Standard AI prompt (Behavioral)

Researcher prompt engineering - Aim 3

Experimental

Participants receive summaries generated after researchers complete AI prompt-engineering training and develop optimized prompts.

干预措施: Experimental: Researcher prompt engineering (Behavioral)

Community co-created AI summaries - Aim 3

Experimental

Participants receive summaries developed through an iterative community-researcher co-creation process following AI training and structured co-design sessions.

干预措施: Community co-created AI summaries (Behavioral)

Co-creation cohort - Aim 2

Experimental

Participants will be divided into three groups, each assigned 1-2 research summaries, and will engage in structured co-creation sessions. The goals of will be to: 1) define readability and appropriateness, 2) review AI-generated drafts produced by the summary engine, and 3) provide feedback to refine prompts and outputs. Several iteration cycles will be conducted as needed, with documentation of any changes and the rationale for making decisions. In this way the team will develop a modular AI "summary engine" that transforms research products (e.g., manuscripts) into draft community-facing materials using co-created prompts and templates. Co-creation will be conducted during one or two facilitated sessions. Each session will include structured review of drafts, guided discussion, and documented decisions regarding readability, transparency, visuals or graphics, etc. Iteration cycles will continue until pre-specified stopping criteria are met.

干预措施: AI literacy training and co-design (Behavioral)

结局指标

主要结局

Confidence in medical research and researchers - Aim 3

时间窗: Immediately following review of research summary, up to 1 hour

This is the primary outcome measure for both Aim 2 and Aim 3. This outcome measure will be assessed using subscale 1 of the PoRT scale. PoRT is a validated, self-report measure that assesses confidence in medical research and researchers. Subscale 1 contains 9 items, with response options for each item ranging from 1 (strongly disagree) to 5 (strongly agree); thus the subscale ranges from 9 to 45. Higher scores indicate higher confidence.

Confidence in medical research and researchers - Aim 2

时间窗: Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour

This is the primary outcome measure for both Aim 2 and Aim 3. This outcome measure will be assessed using subscale 1 of the PoRT scale. PoRT is a validated, self-report measure that assesses confidence in medical research and researchers. Subscale 1 contains 9 items, with response options for each item ranging from 1 (strongly disagree) to 5 (strongly agree); thus the subscale ranges from 9 to 45. Higher scores indicate higher confidence.

次要结局

  • Perceived appropriateness of research summary - Aim 2(Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour)
  • Institutional confidence - Aim 2(Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour)
  • Research comprehension - Aim 2(Immediately before the co-creation process and immediately following the co-creation process, up to 1 hour)
  • Perceived appropriateness of research summary - Aim 3(Immediately following review of research summary, up to 1 hour)
  • Institutional confidence - Aim 3(Aim 3: Immediately following review of research summary, up to 1 hour)
  • Research comprehension - Aim 3(Immediately following review of research summary, up to 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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